scholarly journals Indomethacin Use for the Management of Patent Ductus Arteriosus in Preterms: A Web-Based Survey of Practice Attitudes Among Neonatal Fellowship Program Directors in the United States

2007 ◽  
Vol 28 (3) ◽  
pp. 193-200 ◽  
Author(s):  
S. B. Amin ◽  
C. Handley ◽  
O. Carter-Pokras
2014 ◽  
Vol 190 (2) ◽  
pp. 613-622 ◽  
Author(s):  
Jun Tashiro ◽  
Bo Wang ◽  
Juan E. Sola ◽  
Anthony R. Hogan ◽  
Holly L. Neville ◽  
...  

2014 ◽  
Vol 186 (2) ◽  
pp. 616-617 ◽  
Author(s):  
J. Tashiro ◽  
B. Wang ◽  
J.E. Sola ◽  
A.R. Hogan ◽  
H.L. Neville ◽  
...  

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tim Hundscheid ◽  
Rogier Donders ◽  
Wes Onland ◽  
Elisabeth M. W. Kooi ◽  
Daniel C. Vijlbrief ◽  
...  

Abstract Background Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. Methods/design The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24–72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. Trial registration ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.


2015 ◽  
Vol 26 (6) ◽  
pp. 1107-1114 ◽  
Author(s):  
Jacqueline G. Weinberg ◽  
Frank J. Evans ◽  
Kristin M. Burns ◽  
Gail D. Pearson ◽  
Jonathan R. Kaltman

AbstractObjectiveWe sought to analyse the variation in the incidence of patent ductus arteriosus over three recent time points and characterise ductal ligation practices in preterm infants in the United States, adjusting for demographic and morbidity factors.MethodsUsing the Kids’ Inpatient Database from 2003, 2006, and 2009, we identified infants born at ⩽32 weeks of gestation with International Classification of Diseases, Ninth Revision diagnosis of patent ductus arteriosus and ligation code. We examined patient and hospital characteristics and identified patient and hospital variables associated with ligation.ResultsOf 182,610 preterm births, 30,714 discharges included a patent ductus arteriosus diagnosis. The rate of patent ductus arteriosus diagnosis increased from 14% in 2003 to 21% in 2009 (p<0.001). A total of 4181 ligations were performed, with an overall ligation rate of 14%. Ligation rate in infants born at ⩽28 weeks of gestation was 20% overall, increasing from 18% in 2003 to 21% in 2009 (p<0.001). The ligation rate varied by state (4–28%), and ligation was associated with earlier gestational age, associated diagnoses, hospital type, teaching hospital status, and region (p<0.001).ConclusionThe rates of patent ductus arteriosus diagnosis and ligation have increased in the recent years. Variation exists in the practice of patent ductus arteriosus ligation and is influenced by patient and non-patient factors.


2013 ◽  
Vol 24 (3) ◽  
pp. 327-331 ◽  
Author(s):  
Hubert A. Benzon ◽  
Gildasio S. De Oliveira ◽  
Courtney A. Hardy ◽  
Santhanam Suresh

2007 ◽  
Vol 12 (3) ◽  
pp. 194-206
Author(s):  
Bart Van Overmeire

Cyclooxygenase inhibitors have proven efficacy in the treatment of patent ductus arteriosus (PDA). Intravenous indomethacin has been the only approved treatment for PDA available in the United States for the past 20 years. The armamentarium has recently been expanded with the approval of intravenous ibuprofen lysine in 2006. Ibuprofen lysine has been used for years in Europe, and the author reviews the extensive published literature. This review addresses common questions about ibuprofen lysine, summarizes the available literature, and discusses the data submitted to the Food and Drug Administration (FDA) in support of its approval. Three major trials served as the approval basis for the safety and efficacy of ibuprofen lysine. The author has summarized these studies and, where appropriate, presents pooled results from additional analyses that have not been previously published. Many practical questions regarding the drug, including dosing, administration, and storage are addressed. The results of recently completed but unpublished tests on stability and compatibility with commonly used drugs in the neonatal setting are also reviewed. Ibuprofen lysine now represents an alternative pharmacological option to surgery for the treatment of PDA.


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